Compounded SEMAGLUTIDE 5MG - Lyophilized Powder + Sterile Water for Injection

This is a prescription-only medicine and a compounded medication. The law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed. Keep Out of Reach of Children

WHAT’S IN THE BOX: Your package should include:
a. One (1) Multi-dose Vial of Semaglutide 5mg Subcutaneous Injection - Lyophilized Powder for Reconstitution
b. One (1) 5mL Non-bacteriostatic Sterile Water for Injection (SWFI) ampule
c. One (1) 10mL Syringe NOTE: for reconstitution only
d. Five (6) Alcohol Swabs
e. Six (6) 1mL Syringes (“Insulin Syringes”)

Indications / Uses of SEMAGLUTIDE 5MG (Compounded) - Lyophilized Powder for SC Injection

Label: Semaglutide 5mg Subcutaneous Injection - Lyophilized Powder for Reconstitution in Multi-dose Vial with 2mL Non-bacteriostatic Sterile Water for Injection (SWFI).

Purpose: to help adults with obesity, or adults with overweight who also have weight-related medical problems, to effectively lose excess body weight and maintain the weight loss. To reduce the risk of major cardiovascular events such as death, heart attack, or stroke in adults with known heart disease and with either obesity or overweight. To manage diabetes in adults by regulating blood sugar levels, which can lead to improved overall health. Semaglutide should not be used with other semaglutide-containing products or other GLP-1 receptor agonist medicines.

Instructions: Administer as directed by your healthcare provider. The medication is typically given as a subcutaneous injection in the abdomen, thigh, or upper arm. Rotate injection sites with each dose to avoid irritation.

Dosing: Dosing should be directed by your doctor. The standard dosing is provided below:

• 0.25mg (0.1mL) each week for weeks 1 to 4
• 0.5mg (0.2mL) each week for weeks 5 to 8
• 1mg (0.4mL) each week for weeks 9 to 12
• 1.5mg (0.6mL) each week for weeks 13 to 16
• 2mg (0.8mL) each week for weeks 17 and onward

Missed Dose: If a dose is missed, administer a missed dose as soon as possible within 5 days. If more than 5 days have passed, skip the missed dose and resume your regular schedule.

Reconstitution and Administration Instructions

Reconstitution Instructions:

• Clean your hands thoroughly and set up all components on a clean, organized surface.
• Wipe down any surfaces to eliminate potential contamination and prepare a designated sharps container for used needles.
• Examine all components, including multi-dose vials and syringes, to ensure they are intact, of good quality, and free of defects.
• Carefully twist open the cap of the 2mL non-bacteriostatic SWFI ampule and set it aside in an upright position.
• Remove the cap from the multi-dose vial to expose the rubber top and set it upright.
• Use an alcohol swab to wipe and disinfect the rubber top of the multi-dose vial and place the used swab on its original packaging for disposal.
• Using the 10mL syringe, draw 2mL of the non-bacteriostatic SWFI from the ampule.
• With one hand, hold the filled syringe steady, and with the other hand, insert the needle into the rubber top of the multi-dose vial.
• Slowly push the plunger to introduce the non-bacteriostatic SWFI into the vial, then mix the vial until a clear solution is achieved, removing the syringe once mixing is complete.
• Dispose of the used needle immediately in the designated sharps container.

Avoiding Needle-Stick Injury:

• Use a one-handed technique when recapping used needles.
• Keep your workspace clutter-free to prevent accidents.
• Remove any potential sources of distraction or disturbance.
• You may use gloves and protective gear when handling needles.
• Report any needle-stick incidents immediately to a healthcare provider.

 Administration Instructions:

• Clean your hands and prepare a clean, organized surface with the reconstituted multi-dose vial, a 1mL syringe, and an alcohol swab.
• Wipe down surfaces to eliminate contamination and prepare a designated sharps container.
• Inspect all components to ensure they are intact and free of dirt or defects.
• Shake the reconstituted multi-dose vial to ensure the solution is uniform.
• Use an alcohol swab to disinfect the rubber top of the vial and dispose of the swab properly.
• While the syringe is empty, insert the syringe into the vial then draw the prescribed dose.
• Set the vial aside after filling the syringe, ensuring you measure accurately (i.e., use the top part of the plunger seal to measure the appropriate volume).
• For injection, pinch the skin and insert the needle at a 45º angle into the abdomen, thigh, or upper arm, rotating sites to prevent irritation.
• Inject the medication slowly and leave the needle in for 5 seconds after injecting.
• Remove and dispose of the needle in the sharps container.

Expected Results

Effectiveness:  Semaglutide mimics the hormone GLP-1, enhancing insulin secretion, reducing appetite, and slowing gastric emptying, leading to better glucose control and weight loss.

Onset: Improvements in blood sugar control may be observed within a few days, with weight loss effects noticeable within weeks to months of consistent use.

Clinical Evidence: Clinical trials have shown Semaglutide to significantly reduce HbA1c levels and promote weight loss in adults, supporting its use in diabetes and weight management.